Subsidence of Cementless Stem Following Arthroplasty for Fracture Neck of Femur

Hip Arthropathy Clinical Trial

Official title:

Subsidence of Cementless Stem Following Arthroplasty for Fracture Neck of Femur

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05670717
• Other study ID #: Subsidence of Cementless Stem
• Status: Not yet recruiting
• Start date: February 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Amgad Rasmy Moreed Gerges, fellow
• Phone: 01205302836
• Email: Amgad.20133877[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assessment of subsidence of cementless stem following arthroplasty for fracture neck of femur.

Description:

Neck of femur fractures are occurring at an increased incidence, Functionally independent patients without cognitive impairment can expect reasonable life expectancy, this indicates the need for a durable surgical option that optimises the chance to return to pre-injury functional status, with minimal risk of complications and reoperation. THA should be considered the gold standard producing better functional and quality of life outcomes lower reoperation rates and better cost effectiveness.

THA is associated with better functional outcomes and a lower risk of revision surgery in self-sufficient, physically active patients , Instability is the leading complication of conventional THA and occurs with a higher incidence ,THA remains the option of choice as it provides better functional outcomes.

Although the clinical outcomes of total hip arthroplasty (THA) in elderly patients with femoral neck fracture were reported to be better than hemiarthroplasty, hemiarthroplasty was frequently recommended in cases where the patient has a low functional level and/or osteoporosis and high rates of postoperative dislocation of total hip arthroplasty.

Hip joint replacement surgery is considered one of the most successful operations due to its high success and low complication rate , one possible risk factor for early failure of total hip arthroplasty (THA) is the subsidence of the femoral stem , Cementless THA in particular could be susceptible to subsidence.

Cementless femoral stems ideally achieve direct integration between the stem surface and endosteal bone with the aim of decreasing the incidence of aseptic loosening.

Subsidence is defined as a distalization of the femoral stem in reference to the greater trochanter.

Measurement of subsidence of uncemented femoral stems can be used to evaluate the likelihood of long term stem component loosening and therefore clinical failure .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• cases that underwent cementless hip arthroplasty for fracture neck of femur

Exclusion Criteria:

• 1- malignancy. 2- Previous plating. 3- Revision for infection. 4- dysplasia. 5- SLE and Rheumatoid Arthritis

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Hip Arthropathy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Al-Najjim M, Khattak U, Sim J, Chambers I. Differences in subsidence rate between alternative designs of a commonly used uncemented femoral stem. J Orthop. 2016 Jul 5;13(4):322-6. doi: 10.1016/j.jor.2016.06.026. eCollection 2016 Dec. — View Citation

Burgers PT, Van Geene AR, Van den Bekerom MP, Van Lieshout EM, Blom B, Aleem IS, Bhandari M, Poolman RW. Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures in the healthy elderly: a meta-analysis and systematic review of randomized trials. Int Orthop. 2012 Aug;36(8):1549-60. doi: 10.1007/s00264-012-1569-7. Epub 2012 May 24. — View Citation

Guyen O. Hemiarthroplasty or total hip arthroplasty in recent femoral neck fractures? Orthop Traumatol Surg Res. 2019 Feb;105(1S):S95-S101. doi: 10.1016/j.otsr.2018.04.034. Epub 2018 Nov 16. — View Citation

Hoskins W, Webb D, Bingham R, Pirpiris M, Griffin XL. Evidence based management of intracapsular neck of femur fractures. Hip Int. 2017 Sep 19;27(5):415-424. doi: 10.5301/hipint.5000519. Epub 2017 Sep 11. — View Citation

Leiss F, Gotz JS, Meyer M, Maderbacher G, Reinhard J, Parik L, Grifka J, Greimel F. Differences in femoral component subsidence rate after THA using an uncemented collarless femoral stem: full weight-bearing with an enhanced recovery rehabilitation versus partial weight-bearing. Arch Orthop Trauma Surg. 2022 Apr;142(4):673-680. doi: 10.1007/s00402-021-03913-0. Epub 2021 May 21. — View Citation

Mazoochian F, Schrimpf FM, Kircher J, Mayer W, Hauptmann S, Fottner A, Muller PE, Pellengahr C, Jansson V. Proximal loading of the femur leads to low subsidence rates: first clinical results of the CR-stem. Arch Orthop Trauma Surg. 2007 Aug;127(6):397-401. doi: 10.1007/s00402-007-0384-x. Epub 2007 Jun 30. — View Citation

Parvizi J, Keisu KS, Hozack WJ, Sharkey PF, Rothman RH. Primary total hip arthroplasty with an uncemented femoral component: a long-term study of the Taperloc stem. J Arthroplasty. 2004 Feb;19(2):151-6. doi: 10.1016/j.arth.2003.10.003. — View Citation

Ries C, Boese CK, Dietrich F, Miehlke W, Heisel C. Femoral stem subsidence in cementless total hip arthroplasty: a retrospective single-centre study. Int Orthop. 2019 Feb;43(2):307-314. doi: 10.1007/s00264-018-4020-x. Epub 2018 Jun 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of subsidence of cementless stem following arthroplasty for fracture neck of femur.	Radiological evaluation of stem subsidence by standing anteroposterior radiograph on hip joint 1 year post-operatively to be compared with the previous anteroposterior hip radiograph that was done immediately after operation and assessment of subsidence by measuring the distance between the apex of major trochanter and the stem shoulder or measuring the distance between stem shoulder of hip prosthesis and the most prominent point of lesser trochanter	an average of 1 year post operatively
Secondary	1- Harris Hip Scoring for assessment pain and distance walked and range of motion and quality of life. 2- Health Survey (SF-36) Scoring.foe assesment of health ststus and daily activities 3- Any complications detected.		1 year after surgery.